Using BGMs in a Hospital Setting: A Q&A with CAP and CMS - CD

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This is a recorded version of an AACC live webinar that
was held July 16, 2014. The Food and Drug Administration (FDA) released draft
guidance in 2014 that outlined submission requirements for point-of-care (POC)
blood glucose meters (BGMs) used in professional settings. During public
discussions, questions emerged about the regulatory and accreditation
requirements for using these devices in hospitals, particularly when using them
for purposes or in populations that are not listed in the product labeling.
During this program, representatives from the Centers for Medicare and Medicaid
Services (CMS) and the College of American Pathologists (CAP) discuss how each
oversees POC BGMs in hospital settings, including:

The current requirements associated with these devices;

Verifying performance when introducing new meters;

Validating POC BGMs for off-label uses;

Distinguishing between special general hospital populations and the
regulatory responsibilities for each; and

Common errors inspectors are finding and how to address them.

A Q&A session from the live webinar is also included
on the recording.